Informations générales (source: ClinicalTrials.gov)
Comparison of the 1-min Sit-to-Stand Test to the 6-minute Walk Test in the Respiratory Functional Assessment of Pulmonary Fibrosis: a Cross-over Trial (LaMinute_FIP)
Interventional
N/A
Fondation Hôpital Saint-Joseph (Voir sur ClinicalTrials)
août 2022
décembre 2024
29 juin 2024
Fibrosing interstitial lung diseases or pulmonary fibrosis represent a heterogeneous
group of progressive pulmonary pathologies, responsible for a significant
morbi-mortality. They are defined by an infiltration of the pulmonary interstitium
associating in a variable way an inflammatory component (deposit of inflammatory cells)
and a fibrosing component (deposit of collagen). Idiopathic pulmonary fibrosis (IPF) is
the most common and most severe pulmonary fibrosis. Other pulmonary fibroses are mainly
represented by non-specific interstitial lung disease, pulmonary fibroses associated with
connectivites, hypersensitivity pneumonitis, certain pneumoconiosis (occupational
diseases) and sarcoidosis. The process of fibrosis is responsible for a loss of
elasticity of the lung, leading to a decrease in lung volumes associated with an
alteration of gas exchange.
In these diseases, the clinician must be able to rely on reliable means to assess the
severity of the disease based mainly on the measurement of lung volumes and gas exchange,
at diagnosis and in the follow-up of the patient, in order to propose the most
appropriate management. Lung volumes are assessed by respiratory function tests. Forced
vital capacity is the reference volume value used. Impaired gas exchange is assessed at
rest by measuring carbon monoxide diffusion capacity, arterial oxygen saturation and
arterial blood gases.
The functional capacity to exercise is also a very important evaluation criterion in
terms of prognosis and in the follow-up of the patient. It is assessed by means of
ergocycle tests which mainly determine the maximal oxygen consumption. These are
relatively complex tests that require special equipment and are not routinely performed.
Simpler field tests have been developed to assess functional capacity during exercise,
the most widely used and validated being the 6-minute Walk Test (TM6).
Other field tests to assess functional capacity to exercise have been developed, such as
the 30-second, 1-minute, and 3-minute chair lift tests, stepper tests, and step and stair
tests. Among them, the 1-minute chair lift test (TLC1) is the best evaluated. It consists
of sitting down and getting up from a chair as many times as possible in 1 minute. The
criteria measured are mainly the number of lifts and desaturation. Thus, the fundamental
advantage of the TLC1 over the TM6 is the exemption from temporal and spatial constraints
since it takes only a few minutes and can be performed in a medical office. While TLC1
seems to be the most suitable, there are still a few pitfalls in substituting TLC1 for
TM6 during diffuse interstitial lung disease.
First, there is only one study reporting the results of TLC1 in a healthy population. It
provides a chart of results according to age. Unfortunately, only the number of lifts is
reported without any data on heart rate, SaO2 or sensation of dyspnea.
In respiratory pathologies, TLC1 has been studied mainly in patients with chronic
obstructive pulmonary disease (COPD) and little in PID. Unlike TM6, TLC1 is reproducible
and has no learning effect in this population. Interestingly, one study found that peak
desaturation and peak oxygen consumption occurred during the recovery phase some seconds
after the end of the test.
Studies on TLC1 during SID do not allow us to conclude that this test can substitute for
TM6. However, investigators may note certain limitations, in particular the small number
of patients studied and the retrospective nature of the 2 largest of them. Above all, it
seems that the use of TLC1 could be optimized by taking into account the recovery phase
in the evaluation of desaturation.
The hypothesis of our study is that the TLC1 taking into account the recovery phase can
replace the TM6 in the management of fibrosing PID for prognostic evaluation, patient
follow-up and indication of oxygen therapy. It is more accessible and its use by all
practitioners in face-to-face or telemedicine would allow a better management of these
patients. Finally, the investigators hypothesize that the TLC1 will result in lower costs
in the management of these patients.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| GH PARIS SITE SAINT JOSEPH | Helene BEAUSSIER, PharmD, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Patient whose age is ≥ 18 years
- Patient with fibrosing interstitial lung disease
- French-speaking patient
- Patient affiliated to a health insurance plan
- Patient who has given free, informed and written consent
- Patient whose age is ≥ 18 years
- Patient with fibrosing interstitial lung disease
- French-speaking patient
- Patient affiliated to a health insurance plan
- Patient who has given free, informed and written consent
- Patient with an exacerbation of fibrosis in the last 6 months
- Patient with comorbidities limiting exercise performance
- Distance traveled < 200m at TM6
- Patient on long-term oxygen therapy (LTO)
- Patient already included in a type 1 interventional research protocol (RIPH1)
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under court protection
- Pregnant or breastfeeding patient